SILVER SPRING, MD – Boston Scientific is voluntarily recalling two core wires for its Rotablator Rotational Atherectomy System, according to an alert from the US Food and Drug Administration (FDA). The agency identified both the RotaWire Elite Guidewire and the wireClip Torquer Guidewire as part of a Class I recall.
The manufacturer started recalling the guidewires back in October because of the possibility of cracking and separation that could lead to tamponade, MI and/or fragment migration. In fact, there have been three adverse events reported from these occurrences, including one death after a patient underwent an intervention to remove the damaged wire.
A recall is signified as Class I if device use "may cause serious injuries or death." The guidewire recall is for products created between June 26, 2015 and September 10 and includes 600 units distributed in 17 states, according to the FDA.
In their letter, which was dated October 9, 2015 and titled "Urgent Medical Device Recall Removal—Immediate Action Required," the manufacturer instructed healthcare professionals to stop using the devices and to notify any affected customers. It also explained how to contact the company and how to return the affected products.
Clinicians and consumers can report adverse events from use of these products or any quality problems by calling Boston Scientific at 1-800-811-3211 1-800-811-3211 or by contacting the FDA’s MedWatch reporting program online.
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Cite this: FDA: Guidewires for Rotablator Atherectomy Catheter Recalled - Medscape - Dec 01, 2015.